Brand Name(s): Alagesic, Amaphen, Americet, Anolor, Anoquan, Arcet, Butace, Endolor, Esgic, Esgic Plus, Ezol, Fioricet, Medigesic, Pacaps, Repan, Tencet, Zebutal

Generic Name Acetaminophen, Butalbital, and Caffeine

What are acetaminophen-butalbital-caffeine tablets or capsules?

ACETAMINOPHEN-BUTALBITAL-CAFFEINE (Fioricet^®, Esgic^®, Endolor^®, and others) is a combination product used to treat certain types of headaches and migraines as well as mild to moderate pain. Federal law prohibits the transfer of acetaminophen-butalbital-caffeine to any person other than the patient for whom it was prescribed. Do not share this medicine with any one else. Generic acetaminophen-butalbital-caffeine tablets and capsules are available.

What should my health care professional know before I take acetaminophen; butalbital; caffeine?

They need to know if you have any of these conditions:

• anemia
• attempted suicide
• diabetes mellitus
• drink more than 3-alcohol containing drinks per day
• drug abuse or use of illicit drugs
• heart disease
• high or low blood pressure
• infection
• kidney disease
• liver disease
• lung disease or breathing difficulties
• mental depression or mental problems
• peptic ulcer disease
• porphyria
• thyroid disease
• an unusual or allergic reaction to acetaminophen, butalbital or other barbiturates, caffeine, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I take this medicine?

Take acetaminophen-butalbital-caffeine tablets or capsules by mouth. Follow the directions on the prescription label. Swallow the tablets or capsules with a drink of water. If acetaminophen-butalbital-caffeine upsets your stomach, take it with food or milk. Do not take your medicine more often than directed.

Contact your pediatrician or health care professional regarding the use of this medicine in children. Special care may be needed.

Do not share this medicine with anyone.

What if I miss a dose?

If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What drug(s) may interact with acetaminophen-butalbital-caffeine?

• alcohol
• cyclosporine
• corticosteroids
• female hormones, including contraceptive or birth control pills
• grapefruit juice
• medicines for high blood pressure or other heart problems
• medicines for depression or other mental health problems
• medicines for pain
• medicines to control heart rhythm
• quinine
• seizure medicine
• theophylline
• warfarin

Because acetaminophen-butalbital-caffeine can cause drowsiness, other medicines that also cause drowsiness may increase this effect of acetaminophen-butalbital-caffeine. Some other medicines that cause drowsiness are:

• alcohol-containing medicines
• certain antidepressants or tranquilizers
• muscle relaxants
• certain antihistamines used in cold medicines

Tell your prescriber or health care professional about all other medicines that you are taking, including non-prescription medicines, nutritional supplements, or herbal products. Also, tell your prescriber or health care professional if you are a frequent user of drinks with caffeine or alcohol, if you smoke, or if you use illegal drugs. These may affect the way your medicine works. Check with your health care professional before stopping or starting any of your medicines.

What side effects may I notice from taking acetaminophen-butalbital-caffeine?

Side effects that you should report to your prescriber or health care professional as soon as possible:

• bone tenderness
• changes in behavior, mood, or mental ability
• seizures
• difficulty breathing or shortness of breath
• eye problems, very small or enlarged centers to the eyes
• fever, sore throat
• hallucinations
• lightheadedness or fainting spells
• redness, blistering, peeling or loosening of the skin, including inside the mouth
• skin rash, itching, hives
• slow or fast heartbeat
• swelling of the face or lips
• unusual bleeding or bruising, pinpoint red spots on the skin
• unusual tiredness or weakness
• yellowing of skin or eyes

Side effects that usually do not require medical attention (report to your prescriber or health care professional if they continue or are bothersome):

• confusion, agitation
• trembling
• increased frequency passing urine
• constipation
• clumsiness, unsteadiness, or a "hang-over" effect
• difficulty sleeping or nightmares
• drowsiness, dizziness
• headache
• irritability, nervousness
• nausea or vomiting

What should I watch for while taking acetaminophen-butalbital-caffeine?

Visit your prescriber or health care professional for regular checks on your progress.

After taking acetaminophen-butalbital-caffeine you may get a residual hangover effect that leaves you drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how acetaminophen-butalbital-caffeine affects you. To reduce dizzy or fainting spells, do not sit or stand up quickly, especially if you are an older patient. Avoid alcoholic drinks while you are taking acetaminophen-butalbital-caffeine. Alcohol can increase possible damage to your liver and can increase possible unpleasant effects.

Acetaminophen-butalbital-caffeine can stop birth control pills (oral contraceptives) from working properly. Use another method of birth control while you are taking acetaminophen-butalbital-caffeine.

If you have been taking caffeine or butalbital on a regular basis, you can get withdrawal symptoms if you stop taking them. Symptoms include tiredness, dizziness, headache, anxiety, or nervousness. Try to avoid foods and drinks that contain caffeine while taking acetaminophen-butalbital-caffeine.

Do not take acetaminophen-butalbital-caffeine with other non-prescription medicines, especially cold and allergy medicines without asking your prescriber or health care professional for advice. Grapefruit juice may increase the effects of acetaminophen-butalbital-caffeine.

Many non-prescription medicines contain acetaminophen as an ingredient. Always read the labels carefully to avoid taking an accidental overdose, which can be dangerous.

If you are receiving cancer chemotherapy or other immunosuppression medicine, do not take acetaminophen-butalbital-caffeine with out checking with your prescriber or health care professional. Acetaminophen-butalbital-caffeine may hide the signs of an infection such as fever or pain.

If you are going to have surgery, tell your prescriber or health care professional that you are taking acetaminophen-butalbital-caffeine.

Where can I keep my medicine?

Keep out of the reach of children in a container that small children cannot open.

Store at room temperature between 15 and 30 °C (59 and 86 °F). Keep container tightly closed. Throw away any unused medicine after the expiration date.